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Articles by Catherine Drew
MHRA backs microbiome-based medicines and pilots cut to clinical trial approvals
Microbiome-based medicines are an emerging class of potentially highly innovative and personalised treatments. They are products that can alter, replace or restore the collection of microorganisms that live in and on the human body, together with their genetic material. Currently, no MBMP has been approved for sale in the UK, though some products have been used in clinical trials and been supplied under special unlicensed manufacturing arrangements.
Excipients ineligible for EU supplementary protection certificates, says court adviser
Excipients are inactive substances formulated alongside active pharmaceutical ingredients to aid in drug delivery, stability, and manufacturing.
Medicines regulation
We navigate the complex landscape of pharmaceutical regulations to ensure your innovations reach the market safely and efficiently. Supporting the development of clients’ cutting-edge treatments through ensuring that regulatory requirements are met in a rapidly changing healthcare landscape. Ensuring clients’ pharmaceutical products adhere to both legal and regulatory standards. Providing expert guidance, personalised support, proactive market access strategies for clients’ products.
UK and EU SPC law remains aligned after latest ruling
Gareth Morgan and Catherine Drew, experts in life sciences regulation at Pinsent Masons, said that while alignment gives businesses certainty, the way it could be applied to certain types of pharmaceutical products could create challenges for industry. SPCs enable pharmaceutical patent holders to effectively extend the period for which they can exercise monopoly rights over the sale of medicinal products they have invested a lot of time and money into developing.
EU and US launch joint AI principles for medicines industry
The European Medicines Agency and the American Food and Drug Administration have jointly identified 10 principles which they categorise as representing good practice for AI usage in medicine processes, covering areas such as evidence monitoring and risk assessment.
Biotech innovation to get added EU patent-like protection
Proposals to extend the supplementary protection certificate (SPC) for “best-in-class biotechnology medicines” developed in the EU are included in a new European Biotech Act put forward by the European Commission. The draft new legislation (258-page / 1.93MB PDF) is at the centre of a broader package of measures the Commission has set out that are designed to make the EU health sector “more innovative, competitive and resilient”.
Considerations and strategies for pharmaceutical companies before the UPC
Though pharma IP owners have been reticent to use the Unified Patent Court to date, the number of drug patent cases is set to rise significantly, write experts from Pinsent Masons. As the UPC continues to establish itself as a leading forum for patent disputes, with an increasing number of appeal decisions gradually clarifying key legal questions, engagement by the pharmaceutical sector is starting to come alive.
Planned Parenthood IS "Pro-healthcare"
Re: Letter to the Editor, 12/4/2025 by Lupita Carreno In early December, The Desert Review published a Letter to the Editor, written by Lupita Carreno, who is upset that the “many valuable services” the CUHSD listed as resources for students–and their families– included the medical offices of Planned Parenthood. Ms. Carreno decries Planned Parenthood as “not a neutral health provider”. Of course, my gynocologist is not a “neutral health provider” either.
UK pharma reimbursement scheme reform trailed
Gareth Morgan and Catherine Drew of Pinsent Masons were commenting after the Financial Times reported that the UK government is set to make concessions to pharmaceutical companies over drugs reimbursement – potentially as part of a wider agreement the government might strike with the US – at a time of significant economic uncertainty for the industry.
EMA biosimilars policy shifts over clinical efficacy studies
Tracey Roberts, Catherine Drew and Carly van der Beek of Pinsent Masons were commenting after the European Medicines Agency (EMA) acknowledged that manufacturers of biosimilars can satisfy conditions for obtaining marketing authorisation for their products without having to undertake clinical efficacy studies (CES). “A tailored approach for clinical development of biosimilar candidates can be envisioned,” the EMA said in a draft reflection paper opened to consultation on Tuesday.
UK pharmaceutical report highlights investment concerns for industry
The ABPI statement centres around the government-imposed medicine levy, with firms within the industry claiming that the this makes the country “uninvestable”. The concerns relate to the sustainability of the current levy, which requires companies to pay a portion of their revenue from branded medicines to the National Health Services (NHS).
Biotech’s UK SPCs application fails over nature of ‘active ingredients’
A new ruling provides important guidance to pharmaceutical companies on when a medicinal product can be deemed a combination of active ingredients and shows that what companies disclose in regulatory documents can influence whether those products are eligible for SPCs, experts have said.
UK can learn from US to boost life sciences industry, say experts
Gareth Morgan and Catherine Drew of Pinsent Masons, specialists in advising life sciences companies, were commenting after research commissioned by the Association of the British Pharmaceutical Industry (ABPI) found that the Medicines and Healthcare Regulatory Authority (MHRA) has “gone through a period of strain regarding its operating and performance levels” and that “challenges” relating to the MHRA’s performance in some areas threatens the UK’s competitiveness, including around its...
Baby banks demand help for UK's financially pressured families
Charities in the UK are calling for more help for struggling families with young children, amid concern about the rising prices of baby essentials, particularly baby formula. Baby banks, where parents can pick up clothing and food, have reported an increased demand for help. "With winter approaching, we know people will get huge energy bills, and we know the demand on our services will at least triple," Samia Bandani tells CGTN Europe.
Baby banks demand help for UK's financially pressured families
Charities in the UK are calling for more help for struggling families with young children, amid concern about the rising prices of baby essentials, particularly baby formula. Baby banks, where parents can pick up clothing and food, have reported an increased demand for help. "With winter approaching, we know people will get huge energy bills, and we know the demand on our services will at least triple," Samia Bandani tells CGTN Europe.
Drones to revolutionize farming – saving cash, work and the planet
"This is a first for me, seeing the drone lift off in the UK." Justin Gong is smiling as he watches XAG's P100 take off in a field in Shropshire, in central England. The co-founder of the Chinese drone developer and manufacturer has been in the UK visiting the first-of-its-kind specialist training for drone spraying on farms. It comes as the Guangzhou-based company has won the first, and so far, only license to spread and spray on farms from UK aviation authorities.
Homelessness in London: Why it is becoming unmanageable
One in 50 Londoners are homeless and housed in temporary accommodation, according to a group representing London's 32 borough councils, which describes the situation as an unfolding disaster. The group London Councils say there has been a 110 percent rise in homeless families placed in temporary accommodation over the past year. One of them is Piotr Rembikowski, who has been housed in two different budget hotels for a year, with his wife and two sons, aged 15 and 20.
UK's royal Swan Uppers lament majestic bird's population fall
In a custom that dates back to the 12th century, representatives of the British royal family take to a flotilla of boats to count the swans along a stretch of the river Thames. The practice is known as Swan Upping. Six small rowing boats, each with three crew along with support boats, cruise a stretch of river, covering 127 kilometers in five days. The Swan Uppers, as they are known, capture, tag, weigh and measure the birds in a bid to track their health.
Deep-sea mining: Crucial or criminal?
A gold rush to mine the ocean's depths, no matter the environmental devastation caused. That's how some groups are describing efforts to allow large-scale commercial mining of the deep seas in a bid to collect metals needed to help accelerate the world's green revolution. "The deep-sea environment is particularly vulnerable and fragile; it's a slow-moving environment, things take a long time to grow, to reproduce," Emma Wilson of the Deep Sea Conservation Coalition told CGTN Europe.
'London's creepiest museum' reopens
As museums around the world come to terms with their colonial pasts, the Hunterian Museum is open about its own ethical questions. It's asking visitors not to take photos of the human remains. Many would have been the products of grave robbers who supplied the bodies they dug up to medical schools.
Who is Britain's King Charles III?
There was also public excitement when Charles married his long-time partner Camilla Parker Bowles in 2005, decades after they had first been romantically involved. Having led the country in mourning following the death of Queen Elizabeth the second, for many he is a man who is finally fulfilling his destiny.
EU to link pharma incentives to public health objectives
Patent law expert Jules Fabre of Pinsent Masons said a further significant change proposed is to the ‘Bolar’ exemption, which he said has, in its current form, been implemented in different ways by member states. The existing exemption enables medicines manufacturers to use patented products when developing medicines for the purposes of obtaining marketing authorisation.
EU pharma law reform faces further delay
In its review, the Commission said it was considering potential reform in a wide range of areas including in relation to unmet medical needs; improving access to and affordability of medicines; addressing antimicrobial resistance, ensuring security of supply of medicines, adapting the regulatory approach to account for “novel products”; and environmental challenges. An announcement on the next steps towards reform was initially expected before the end of 2022.
Budget 2023: enhanced tax credit for R&D intensive businesses welcomed
Significant changes to the UK’s R&D tax credits system are being introduced from April 2023 as part of a government-led review into the R&D tax relief system. The repayment element of R&D tax credits for SMEs is being cut from 14.5 to 10% from 1 April 2023, whilst the additional tax deduction for R&D costs for SMEs is also being cut – from 130% to 86%. The rate of the research and development expenditure credit (RDEC) is rising from 13% to 20%. However, this predominantly targets larger businesses.
Chinese market offering sparkle to French wine after COVID and drought hangover
French wine exports to China, which had been falling in recent years, were severely impacted by COVID-19 restrictions. But with the country fully reopened, optimism is growing. "We hope for a rebound in our exports to China," Bernard Farges said. He is the president of CNIV, a national committee of wines with Geographical Indicator status. These are certified as having been produced from a certain region like Bordeaux and are at the more expensive end of the market.
Is this really Champagne? How blockchain technology boosts business, consumers and farmers
Blockchain is a shared unchangeable ledger that allows the process of recording transactions and tracking assets. It's known around the world as the base of cryptocurrencies. But the technology is increasingly being used in businesses, allowing everyone, including the consumer to see just where products are coming from and where they are going. The produce of France, from wines and cheeses to pork and beef, has been showcased this week at the annual Salon de l'agriculture in Paris.
Could home-grown insect burgers persuade meat-lovers to quit beef?
French company Ÿnsect is seeking to educate a new generation of agricultural workers at the show about its work. Established a decade ago, Ÿnsect uses mealworm beetles to produce protein sources for human and animals, oil and fertilizer using minimal land and water resources. Last year it joined with new partners in the U.S., Mexico and the Netherlands and launched the 'Ÿ burger' in Europe after getting the green light from food regulators.
French farmers hope China will boost 'crucial' pork exports
According to the national pork association, France exported 130,000 tonnes to China in 2022. Some estimates put the trade at $45 million per quarter. The approval of pork producers is a key concern for French agriculture officials, and has been discussed at the highest official levels. It's been even more pressing in recent years as China's domestic pork production has been hit by outbreaks of African Swine Fever.
EMA clarifies position on biosimilars switching
The clarification (2-page /107KB PDF) builds on a landmark statement issued by the EMA last year in which it, together with the Heads of Medicines Agencies, said that patients can safely be switched onto ‘biosimilar’ medicines in place of the biologic medicines those biosimilars are based on without that reducing treatment effectiveness.
Lion dancers light up Paris's Chinese New Year festivities
A wintry afternoon in Paris hasn't deterred members of the LDFA Academy from rehearsals with lion dancers and musicians warming up in the traditional way. "We celebrate many things through the lion dance. Weddings, festivals and New Year's Day," says one of the dancers, Jean-Luc.
Will King Charles III be as influential a monarch as Queen Elizabeth II?
The year 2022 was a tumultuous one for the British royal family, with the the passing of Queen Elizabeth II, the longest-serving monarch in British history. For the majority of Britons, she was the only monarch they had ever known. She had been the UK's figurehead on the international stage for seven decades and her passing marked a milestone in British history. Tributes were paid to the Queen, head of the Commonwealth group of nations, in all corners of the world.
British batch testing policy to help pharmaceuticals avoid duplication
Catherine Drew of Pinsent Masons was commenting after the government made permanent arrangements that have applied since Brexit, which enable pharmaceutical companies to import medicines to the UK from countries within the EU and wider European Economic Area (EEA) without having to engage in British batch testing or obtain certification from a UK ‘qualified person’.
UK migrant stance draws criticism from Albania
The UK's political row over people illegally crossing the English Channel in small boats to claim asylum has now become an international argument, after Albania's Prime Minister chastised the UK for its handling of the matter. Almost 40,000 people have crossed the Channel in small boats so far this year, the highest number since these figures began to be collected in 2018.
Primacy of national medicines marketing authorisations endorsed by CJEU adviser
The opinion, if followed by the Court of Justice of the EU (CJEU), could make it more difficult for errors made by national regulators to be corrected – to the potential detriment of either manufacturers of originator products or those that make rival generic alternatives, depending on the circumstances.
EU pharma law reforms face delay
The European Commission was expected to outline proposed amendments to the Human Medicines Directive and Regulation by the end of this year, but Politico has reported that an impact assessment on the planned changes has been rejected by the Regulatory Scrutiny Board within the European Commission. The Regulatory Scrutiny Board acts as quality control over major EU legislative initiatives.
'Right to Grow' movement seeks to grow community food on unloved public land
With communities everywhere facing higher costs, the pandemic boom in gardening is now seeing people turn to growing their own food in increasing numbers. As households look to cut bills, UK retailers report a four-fold increase in seed sales. One idea being promoted is to allow people to grow food on unloved public land in towns and cities. Campaigners want the government to force councils to list land that could be used in this way in a "Right to Grow" law.
Could robots fill the UK's service industry staff shortages?
Robots have been waiting on diners in London and while they're a draw for futuristic foodies, they also have practical implications for the wider industry as the UK struggles with staffing shortages in the hospitality sector. Bellabot is the latest employee at the restaurant in Gravity Southside leisure center in the southwest of the capital. It's being trained to deliver food from the kitchen to the dining area, carrying orders the correct table.
Developed countries with past environmental debts 'should make bigger climate contribution'
02:19 China expects developed nations with what it says are historic environmental debts to make the greatest contributions during the COP26 climate conference to be held later this month in Glasgow. China's Chief Climate Negotiator Xie Zhenhua and Vice Minister of Environment Zhao Yingmin told reporters that China is expecting countries to make and meet ambitious targets at COP26.
Farming drones: The future of agriculture?
03:05 Farmers in deckchairs while the robots do the hard work – that's the tongue-in-cheek message from the team behind XAG's Europe debut at the Cereals Live agricultural show. Guangzhou-based drone manufacturer XAG, with a large share of China's domestic drone market, is hoping to venture into Europe. The robot manufacturer hopes its lightweight, electric, autonomous devices could help UK farmers deal with labor shortages and the need to become more environmentally friendly and increase yields.
Big pharma bemoans watered down reforms on health technology assessments
The European Federation of Pharmaceutical Industries and Associations (EFPIA) was commenting after a political agreement was reached by the European Parliament and Council of Ministers on a new EU regulation on HTAs. HTAs are holistic assessments of the medical, social, economic and ethical issues associated with introducing new health technologies, whether medicines, medical devices, surgical procedures or other measures for disease prevention, diagnosis or treatment used in healthcare.
Clinically vulnerable emerge in England and Wales after a year of shielding
02:09 For around 4 million people in England and Wales, April offers a chance of freedom as UK government guidance for the clinically extremely vulnerable to remain at home comes to an end. For some, this day has been a long time coming. One of those is Chris Olivotos, 54, an award-winning cameraman. He's braved war zones and hostile environments, but a kidney condition meant he had to take cover from COVID-19 when ordered to do so. Since then he's been shielding at home.
Israel holds fourth election in two years: What you need to know
Benjamin Netanyahu out campaigning a day before Tuesday's election. /Reuters/Ronen Zvulun Benjamin Netanyahu out campaigning a day before Tuesday's election. /Reuters/Ronen Zvulun Hoping for a clear winner, Israelis go to the polls for a fourth time in two years on Tuesday (23rd March). Some hope it is a chance to get rid of the man who has dominated politics for years and held the post of prime minister for the past 12.
Women call for action on male violence after Sarah Everard's murder
04:08 More than 70 percent of women of all ages reported experiencing some form of sexual harassment in public spaces in Britain. That was one of the conclusions of a report for the UK branch of United Nations Women, which found that 97 percent of women aged between 18 and 24 have experienced sexual harassment. The vast majority of the women surveyed said they didn't report it because they didn't think the incidents were serious enough or because they didn't think reporting would help.
Porsche hopes eFuel will make its cars greener than electric vehicles
03:45 The announcement by Porsche that it is investing more than $28 million to develop synthetic fuels in a bid to make older car models as green as electric ones has been welcomed by many. The German luxury car maker says a cleaner "eFuel", will allow its older models to stay on the road longer. It is promising news for the many classic Porsche fans who want to keep driving their beloved motors. Late football star Diego Maradona's Porsche was put on display before auction in March.
Why UK 'shadow bank' Greensill's collapse is similar to the subprime mortgage crisis
03:28 Companies around the world are still digesting the collapse of London-based specialty fintech company Greensill Capital, which has gone into administration, leaving businesses and thousands of jobs at risk, particularly in the steel industry. Justin Urquhart-Stewart, co-founder of Seven Investment Management, said the collapse of Greensill is reminiscent of the U.S. subprime mortgage crisis of 2007, which contributed to the 2008 Global Financial Crisis.
Regulatory and data changes can incentivise innovation in life sciences
A continuation of regulatory flexibilities deployed during the coronavirus crisis and the introduction of clear guidelines on the use of patient data in health research initiatives can help incentivise innovation in life sciences, legal experts have said.
Australian Open can be 'blueprint' for major sporting events, including Tokyo Olympics
05:04 While the clean-up is under way at the Rod Laver Arena in Melbourne and Novak Djokovic's record-extending ninth victory in the Australian Open is being marveled at, other lessons are also being digested. Like how to stage a major sports event safely despite the pandemic. The Australian Open was not without unforeseen challenges to an already hugely complicated logistical operation.
UK fashion faces challenges from the pandemic and Brexit
02:59 This year, instead of the front row and flashlights, London Fashion Week is taking place across the weekend online, as a digital-only event. Much has changed for the fashion world since the 2020 event when CGTN Europe met stylist turned designer Deborah Latouche, who launched her 'modest fashion' label Saborah at the show. "I do believe in the product, there is a huge gap in the market," she said at the time.
Cause for optimism on climate action, says Chinese environmentalist Ma Jun
03:31 One of China's leading environmental campaigners says he's much more hopeful about the prospects for global action on climate change than he was just six months ago. Ma Jun who leads the Institute of Public & Environmental Affairs, said last week's World Economic Forum (WEF) showed growing international consensus on the need for action.
Endangered male seahorse giving birth to 100 babies captured on video
00:27 The moment a male hippocampus whitei, also known as a White's Seahorse, gave birth to around 100 offspring has been caught on camera at Sea Life Sydney Aquarium. The babies of this endangered species, similar in size to a grain of rice, emerged from their father's pouch. Seahorses are ovoviviparous, with the males of the species brooding eggs in a pouch before giving birth to live young.
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